PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough

Cough Clinical Trial

— PEACe  

Official title:

PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981147
• Other study ID #: PE/PK/PYTUS/SP/2017-01
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2017
• Source: PharmEvo Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of Phytus in Acute Cough

Description:

Common colds are the most frequently encountered human diseases worldwide. Common cold is a conventional term used for mild upper respiratory illnesses, which comprises a heterogeneous group of self-limited diseases caused by numerous viruses. The frequency is age-specific with fewer episodes in adults than in younger children. Cough due to the common cold is probably the most common cause of acute cough. In a significant subset of patients with "post infectious" cough, the etiology is probably an inflammatory response triggered by a viral upper respiratory infection (ie, the common cold). The resultant sub-acute or chronic cough can be considered to be due to an upper airway cough syndrome, previously referred to as postnasal drip syndrome.

Thyme leaf (Thymus vulgaris) expels phlegm and relieves congestion . It is antiseptic and an immune stimulant. The primary chemical constituents of Thyme include essential oil (borneol, carvacrol, cymol, linalool, thymol), bitter principle, tannin, flavonoids (apigenin, luteolin), saponins, and triterpenic acids. Thyme warms and stimulates the lungs, expels mucus, and relieves congestion. It also helps deter bacterial, fungal, and viral infections. The thymol content of thyme works as an expectorant and cough suppressant and is frequently used in cough syrups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 79 Years

Eligibility

Inclusion Criteria:

• Cough attributed to URTI such as the common cold

• Moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment.

• Moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough

Exclusion Criteria:

• Diagnosis of chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies,

• Received antihistamines or any cough medicine the day prior to study entry,Known sensitivity to any component of Phytus

Related Conditions & MeSH terms

• Common Cold
• Cough

Intervention

Drug:
• Phytus (Cisti, Thyme and Ivy Leaves)
Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.

Locations

Country	Name	City	State
Pakistan	KCHS Medical Center 1st Floor, Tipu Sultan Road.	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
PharmEvo Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in day cough score at end of study	A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely)	4 nights (onset of trial Night 1 to Night 4)
Secondary	Change in night cough score at end of study	A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the past night. The scale rates each parameter from 0 (not at all) to 6 (extremely).	4 nights (onset of trial Night 1 to Night 4)